Pfizer to Seek FDA Emergency Use Authorization for Its COVID-19 Vaccine in Late November

The first COVID-19 vaccine could be considered for Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) by November.

In an open letter, Albert Bourla, chief executive officer of Pfizer Inc. (New York, NY, USA), has stated that the company will submit efficacy and safety data for its vaccine candidate BNT-162 being developed in partnership with Biopharmaceutical New Technologies (BioNTech Mainz, Germany) to the FDA for EUA after the third week of November. Bourla stated that in order to seek approval for public use, it must be proved that the COVID-19 vaccine is effective, safe and can be consistently manufactured at the highest quality standards. Pfizer expects to know whether or not its COVID-19 vaccine candidate is effective towards the end of October by when there will be a certain number of COVID-19 cases in its trial for comparing the effectiveness of its vaccine in vaccinated individuals against participants who have been given a placebo.

The decision to apply for EUA for its COVID-19 vaccine candidate ‘soon after’ a safety milestone is reached in the third week of November will ensure that Pfizer complies with the FDA’s recent COVID-19 vaccine development guidance that requires developers to provide safety data from at least half its trial patients taken two months following the final vaccine dose. Following the achievement of a positive efficacy readout and a robust safety profile, Pfizer will finally submit manufacturing data that demonstrates the quality and consistency of its COVID-19 vaccine that will be produced.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” wrote Bourla.

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